DESC:
Technical Field of the Invention

The present invention relates to a vaginal disintegrating film composition for the prevention of urogenital tract infections that combines hyaluronic and lactic acids as active components and pharmaceutically acceptable excipients.

Background of the Invention

Women all over the world frequently suffer from urogenital infections, including urinary tract infections (UTI), bacterial vaginosis (BV), and yeast vaginitis. In their lifetimes, most of women will experience at least one vaginal infection, and many of these will experience the infection again. At the moment, antibiotics are mostly used to treat vaginal infections. However, antibiotics also eliminate beneficial bacteria that are already present in the vaginal environment, such as Lactobacilli, raising the pH of the vaginal environment and raising the risk of bacterial vaginosis recurrence or the emergence of a different vaginal infection, such as a yeast infection. Women who have been diagnosed with bacterial vaginosis are more likely to contract other STIs, and pregnant women are more likely to give birth before their due date.

Various treatments have also been suggested, mostly in relation to estrogens therapy for postmenopausal women. Its use is nevertheless restricted by a few contraindications, and several lubricants or moisturizers have been tried. Two molecules, lactic acid and hyaluronic acid, have been known to have considerable therapeutic advantages in such circumstances.

Hyaluronic acid has a moisturizing effect and is a popular and promising vaginal medical treatment that seems to offer a remedy. Although hyaluronic acid is one of the most widely used chemicals in skincare products, the advantages go far beyond the face. Hyaluronic acid, a naturally occurring substance, has been shown in clinical studies to be an effective treatment for vaginal dryness and its accompanying symptoms of burning, irritation, and painful sex. Hyaluronic acid has the exceptional ability to bind to and hold water; yet, natural loss occurs with ageing. Hyaluronic acid replenishes and maintains moisture by retaining water. Hyaluronic acid has been demonstrated in clinical investigations to help retain the typical cellular architecture found with estrogens and reduce the symptoms of menopausal vaginal atrophy.

Lactic acid at sufficiently acidic pH is a potent microbicide, and lactic acid produced by vaginal lactobacilli may help protect against reproductive tract infections. The growth of fungus, protozoa, and other undesirable microorganisms, which typically require a pH greater than 6.0, is not encouraged by the presence of lactic acid, which allows the preservation of an acidic pH of around 3.5 to 4.5. Contrarily, lactobacilli are acidophilic, which means they thrive in an acidic environment. This helps them to multiply as much as possible. In fact, dangerous microbes that might cause vaginal infections like bacterial vaginosis are blocked from entering the body by the lactic acid and low pH of the vaginal fluid.

Pessaries, vaginal tablets, gels, irrigation solutions, solid foams and ointments are the most often used medicinal dosage forms to be administered vaginally in actual practice. The self-cleaning action of the vagina, which is linked to discomfort and leakage sensation, has been shown to reduce the retention of conventional commercial preparations. These preparations are uncomfortable to apply, frequently require multiple daily administrations to achieve the desired therapeutic outcome, and do not support uniform drug distribution. These traits frequently cause women to be less accepting of vaginal pharmacological forms, which in turn limits the treatment's effectiveness, which is also impacted by the challenge of uniformly dispersing the medication over the vagina. In contrary to this, Vaginal films are pharmaceutical delivery systems that are easy to use, discrete, don't need an applicator to dispense, and disperse in vaginal fluids with little chance of raising fluid volume or leaking out, boosting user comfort and effectiveness after administration. Vaginal films also have the benefits of portability and inexpensive cost per unit dosage form.

The patent application WO2013038402A1 discloses a pharmaceutical composition useful for treating a gynecological condition comprising (a) an active ingredient selected from a group consisting of at least one non-steroidal anti-inflammatory drug (NSAID), danazol and a combination thereof, (b) at least one pharmaceutically acceptable carrier or excipient. In a core aspect of the invention that the composition is adapted to be vaginally administrable further wherein said composition is formed in an immediate release form. Kits and methods using the aforementioned composition are also disclosed. Thin Film type or Pharm Film type or mucoadhesive type excipient is selected from a group consisting of: hydroxypropyl methyl cellulose (HPMC) 4M, Carbopol 934, hyaluronic acid, Gelatin, Mannitol, Citric acid, Chitosan, Sodium Alginate, Cyclodextrins and combination thereof. The pharmaceutical composition of claim 6, wherein said probiotic agent is selected from a group consisting of lactic-acid bacteria such as Lactobacillus rhamnosus, bifidobacterium, streptococcus, factors that stimulate the growth of protective organisms, enzymes, vitamins and cellular factors and mixtures thereof.

Another patent US8486374B2 discloses waterless composition suitable for delivery of an active agent to a body surface or cavity includes a vehicle having about 70% to about 99% by weight of a hydrophilic polar solvent, said hydrophilic solvent selected from the group consisting of (i) a mixture of two or more different polyethylene glycols (PEGs), wherein at least one PEG is a high molecular weight PEG having a melting point greater than 25° C.; and (ii) propylene glycol (PG); about 0% to about 10% of at least one surface active agent; about 0% to about 5% of a polymeric agent; about 0% to about 30% of a secondary hydrophilic solvent; and about 0% to about 5% of a silicone oil; and about 3% to about 25% hydrophobic propellant. The composition is otherwise substantially free of a hydrophobic solvent and includes at least one of a surface-active agent and a polymeric agent. The vehicle and the propellant are sufficiently miscible that the components may be homogeneously distributed with mild shaking.

There are many other patents which provide different types of formulations for vaginal lubrication. However there still exists a need to develop vaginal disintegrating film to augment the body's natural lubrication while moisturizing and lubricating the vaginal epithelium to improve ease and comfort during routine activities.

Conventional vaginal pessaries, vaginal gels, and vaginal liquids have been used for various therapeutic purposes; however, they also come with several disadvantages. Some of the common disadvantages of each are as follows:

Disadvantages of Conventional Vaginal dosage forms:
Discomfort: Vaginal pessaries can cause discomfort or irritation due to their physical presence in the vagina, especially for some women with sensitive vaginal tissues.

Poor Retention: Some women may experience difficulties in keeping the pessaries in place, leading to reduced effectiveness or frequent reinsertion. Vaginal gels and liquids can be rapidly expelled from the vagina, reducing the contact time with the vaginal tissues and potentially decreasing therapeutic effectiveness.

Leaking: Depending on the design and fit, pessaries may sometimes leak, leading to soiling of undergarments and inconvenience. Vaginal gels and liquids may sometimes leak out of the vagina, causing inconvenience and potentially reducing drug absorption.

Allergic Reactions: Some women may develop allergic reactions to the materials used in pessaries, leading to irritation or inflammation and some may experience vaginal irritation or burning sensations due to the ingredients or preservatives present in the gel.

Risk of Infections: Improperly cleaned or contaminated pessaries can increase the risk of vaginal infections, including bacterial vaginosis and yeast infections.

Limited Drug Release: Pessaries, gels and liquids may not always provide a controlled and sustained release of medication, affecting their therapeutic efficacy.

Reduced Drug and Stability Shorter Shelf Life: Some medications may be less stable in gel and liquid formulations, leading to decreased shelf life and potential degradation over time.

Inconsistent Dosage: Ensuring consistent dosage with vaginal liquids can be challenging, potentially affecting treatment outcomes.

Vaginal pH Disturbance: Certain vaginal liquids, especially those with ingredients like douches or strong antiseptics, can disrupt the natural vaginal pH balance, leading to potential adverse effects.

The current invention addresses the above-mentioned problems existing so far and provides an effective solution. The present invention relates to a vaginal dissolving film composition for the prevention of urogenital tract infections that combines hyaluronic and lactic acids as active components and pharmaceutically acceptable excipients. The vaginal dissolving film of our present invention is to augment the body's natural lubrication while moisturizing and lubricating the vaginal epithelium to improve ease and comfort during routine activities.

Objectives of the Invention

The main objective of the present invention is to develop a vaginal disintegrating film composition for the prevention of urogenital tract infections.

The second objective of the present invention is to develop a disintegrating film that combines hyaluronic and lactic acids as active components and pharmaceutically acceptable excipients

Further objective of the present invention is developing a vaginal disintegrating film to augment the body's natural lubrication while moisturizing and lubricating the vaginal epithelium to improve ease and comfort during routine activities.

Brief Summary of the Invention

The following summary is provided to facilitate a clear understanding of the new features in the disclosed embodiment and it is not intended to be a full, detailed description. A detailed description of all the aspects of the disclosed invention can be understood by reviewing the full specification, the drawing and the claims and the abstract, as a whole.

In one aspect of our present invention, the vaginal disintegrating Film composition comprises of Hyaluronic acid (as Sodium Hyaluronate) and Lactic acid combination along-with other active components and pharmaceutically acceptable excipients.

In another aspect of our present invention, the said vaginal disintegrating films are processed to a wet slurry after completion of mixing, then subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry. Then the said wet slurry are casted at pre-defined process parameters and the dried casted film was slitted into required dimensions for achieving the final dose.

Further objects, features, and advantages of the invention will be readily apparent from the following description of the preferred embodiments thereof, taken in conjunction with the accompanying drawings.

Brief Description of the Drawings

The manner in which the present invention is formulated is given a more particular description below, briefly summarized above, may be had by reference to the components, some of which is illustrated in the appended drawing It is to be noted;

However, that the appended drawing illustrates only typical embodiments of this invention and are therefore should not be considered limiting of its scope, for the system may admit to other equally effective embodiments.

Throughout the drawings, the same drawing reference numerals will be understood to refer to the same elements and features.

The features and advantages of the present invention will become more apparent from the following detailed description a long with the accompanying figures, which forms a part of this application and in which:

Fig. 1 illustrates the block diagram describing the method of preparation of one embodiment in accordance with our present invention.

Reference numerals:

100 - Weighed quantity of purified water was taken in a SS container and kept under stirring at 350 RPM
101 - Weighed quantity of Sodium Hyaluronate was added to above step-1 under stirring at 500 RPM for 30 min
102 - Weighed quantity of Lactic acid was added to above step-2 under stirring at 500 RPM for 10 min
103 - Weighed quantity of Sodium Carboxymethyl cellulose was added to above step-3 under stirring at 500 RPM for 10 min
104 - Weighed quantity of Hydroxypropyl methyl cellulose solution was added to above step-4 under stirring at 500 RPM for 15 min
105 - Weighed quantity of Propylene glycol was added to above step-5 under stirring at 500 RPM for 5 min
106 - Weighed quantity of Glycerine was added to above step-6 under stirring at 500 RPM for 5 min
107 - Weighed quantity of Dextrose monohydrate was added to above step-7 under stirring at 500 RPM for 5 min
108 - Weighed quantity of FD&C Blue no.1 was added to above step-8 under stirring at 500 RPM for 5 min
109 - Finally, above step- 9 Wet slurry was stirred at 500 RPM for 30 min to get uniform viscous solution
110 - Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry
111 - The Wet slurry was casted at process parameters of Dr. Knife thickness of 700 to 1200 microns; Temperature 95±3°C; and In-direct drying
112 - The dried casted film was slitted into required dimensions for achieving the final dose.

Detailed Description of the Invention

It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. In addition, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

The use of “including”, “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.

According to an exemplary embodiment of the present invention, relates to a vaginal disintegrating film composition for the prevention of urogenital tract infections that combines hyaluronic and lactic acids as active components and pharmaceutically acceptable excipients.

In one embodiment of the present invention the vaginal disintegrating film augment the body's natural lubrication while moisturizing and lubricating the vaginal epithelium to improve ease and comfort during routine activities.

Example 1

Hyaluronic acid & Lactic acid Vaginal Disintegrating Film
S No. Ingredients Function Range
% w/w
1 Hyaluronic acid (as Sodium Hyaluronate) API 1 - 10
2 Lactic acid API 0.5 - 10
3 Sodium Carboxymethyl cellulose Mucoadhesive Polymer 0.05 - 1
4 Hydroxypropyl methylcellulose Film-forming Polymer 20 - 85
5 Propylene glycol Plasticizer 5.5 - 15.88
6 Glycerine Plasticizer 0.1 - 7
7 Dextrose Monohydrate Diluent 0.5 - 6
8 FD&C Blue no.1 Colorant 0.001 - 0.5
9 Purified water Vehicle Qs

Example 1
A method of preparation of the said vaginal disintegrating films, as given by one embodiment of our present invention comprising of the following steps (as shown in fig 1):
1. Weighed quantity of purified water was taken in a SS container and kept under stirring at 350 RPM (100)
2. Weighed quantity of Sodium Hyaluronate was added to above step-1 under stirring at 500 RPM for 30 min (101)
3. Weighed quantity of Lactic acid was added to above step-2 under stirring at 500 RPM for 10 min (102)
4. Weighed quantity of Sodium Carboxymethyl cellulose was added to above step-3 under stirring at 500 RM for 10 min (103)
5. Weighed quantity of Hydroxypropyl methyl cellulose solution was added to above step-4 under stirring at 500 RPM for 15 min (104)
6. Weighed quantity of Propylene glycol was added to above step-5 under stirring at 500 RPM for 5 min (105)
7. Weighed quantity of Glycerine was added to above step-6 under stirring at 500 RPM for 5 min (106)
8. Weighed quantity of Dextrose monohydrate was added to above step-7 under stirring at 500 RPM for 5 min (107)
9. Weighed quantity of FD&C Blue no.1 was added to above step-8 under stirring at 500 RPM for 5 min (108)
10. Finally, above step- 9 Wet slurry was stirred at 500 RPM for 30 min to get uniform viscous solution (109)
11. Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry (110)
12. The Wet slurry was casted at process parameters of Dr. Knife thickness of 700 to 1200 microns; Temperature 95±3°C; and In-direct drying (111)
13. The dried casted film was slitted into required dimensions for achieving the final dose (112)

The stability data of this embodiment of our present invention is given below:
Example - 1 Stability data
Tests Initial 40°C / 75% RH 30°C / 65% RH 25°C / 60% RH
1M 2M 3M 6M 1M 2M 3M 6M 1M 2M 3M 6M
Description Light Blue coloured films
Identification Retention time of major peak of the sample solution corresponds to that of standard solution, as obtained in assay
Disintegration time 71 sec 70 sec 73 sec 71 sec 71 sec 70 sec 75sec 76 sec 76 sec 72 sec 78sec 76 sec 77 sec
Water Content 6.98% 5.35% 6.07% 5.94% 7.50% 5.01% 6.29% 5.68% 6.61% 4.79% 5.20% 5.03% 7.29%
Assay of Sodium Hyaluronate 110.10% 102.90% 105.20% 102.30% 102.60% 105.30% 101.70% 101.70% 104.80% 106.10% 103.50% 105.20% 102.40%
Assay of Lactic acid 98.10% 97.20% 97.30% 94.90% 94.10% 95.60% 94.50% 98.30% 95.00% 96.20% 96.10% 96.40% 99.90%
Folding Endurance >150 >150 >150 >150 >150 >150 >150 >150 >150 >150 >150 >150 >150
Related Substances
For Sodium Hyaluronate ND ND ND ND ND ND ND ND ND ND ND ND ND
For Lactic acid
Max unknown (%) ND 3.6 1.32 1.64 2.08 3.2 0.61 0.86 1.44 3.1 0.49 0.58 1
Total (%) ND 3.6 1.91 2.2 2.74 3.2 0.91 1.2 2.09 3.1 0.72 0.8 1.46

Another embodiment of our present invention is given below as example 2:
Example 2
Hyaluronic acid & Lactic acid Vaginal Disintegrating Film
S No. Ingredients Function Range
% w/w
1 Hyaluronic acid (as Sodium Hyaluronate) API 1 - 10
2 Lactic acid API 0.5 - 10
3 Sodium Carboxymethyl cellulose Mucoadhesive Polymer 0.1 - 1.5
4 Hydroxypropyl methylcellulose Film-forming Polymer 20 - 85
5 Polyvinyl alcohol Co-Polymer 0.1 - 1.3
6 Polyethylene glycol 400 Plasticizer 1.1 - 6.18
7 Propylene glycol Plasticizer 5.5 - 15.88
8 Glycerine Plasticizer 1.2 - 8.1
9 Dextrose Monohydrate Diluent 0.5 - 6
10 FD&C Yellow no.5 Colourant 0.001 - 0.2
11 Purified water Vehicle Qs
Example 2
A method of preparation of the said vaginal disintegrating films in one another embodiment of our present invention comprises of the following steps:
1. Weighed quantity of purified water was taken in a SS container and kept under stirring at 350 RPM
2. Weighed quantity of Sodium Hyaluronate was added to above step-1 under stirring at 500 RPM for 30 min
3. Weighed quantity of Lactic acid was added to above step-2 under stirring at 500 RPM for 10 min
4. Weighed quantity of Sodium Carboxymethyl cellulose was added to above step-3 under stirring at 500 RPM for 10 min
5. Weighed quantity of Hydroxypropyl methylcellulose solution was added to above step-4 under stirring at 500 RPM for 15 min
6. Weighed quantity of Polyvinyl alcohol was added to above step-5 under stirring at 500 RPM for 15 mins
7. Weighed quantity of Polyethylene glycol 400 was added to above step-6 under stirring at 500 RPM for 15 min
8. Weighed quantity of Propylene glycol was added to above step-7 under stirring at 500 RPM for 5 min
9. Weighed quantity of Dextrose monohydrate was added to above step-8 under stirring at 500 RPM for 5 min
10. Weighed quantity of Glycerine was added to above step-9 under stirring at 500 RPM for 5 min
11. Weighed quantity of FD&C Yellow no.5 was added to above step-10 under stirring at 500 RPM for 5 min
12. Finally, above step- 11 Wet slurry was stirred at 500 RPM for 30 min to get uniform viscous solution
13. Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry
14. The Wet slurry was casted at process parameters of Dr. Knife thickness of 700 to 1200 microns; Temperature 95±3°C; and In-direct drying
15. The dried casted film was slitted into required dimensions for achieving the final dose

The stability data of this embodiment of our present invention is given below:
Example - 2 Stability data
Tests Initial 40°C / 75% RH 30°C / 65% RH 25°C / 60% RH
1M 2M 3M 6M 1M 2M 3M 6M 1M 2M 3M 6M
Description Transparent pale, yellow-coloured films
Identification Retention time of major peak of the sample solution corresponds to that of standard solution, as obtained in assay
pH 3.77 3.65 3.71 3.56 3.74 3.60 3.67 3.45 3.65 3.56 3.69 3.45 3.58
Osmolality (mOsmol/kg) 142 136 138 127 136 141 139 148 140 145 147 144 145
Viscosity (cP) 401.4 129 115.4 92.90 90.70 273 125.4 156.8 133.7 254.7 177.4 164 136
Disintegration time 55 sec 56 sec 55 sec 53 sec 51 sec 56 sec 55 sec 52 sec 51 sec 57 sec 56 sec 52 sec 50 sec
Water Content 5.96% 3.50% 5.82% 4.92% 8.11% 4.09% 5.91% 5.23% 8.05% 3.98% 5.93% 5.28% 8.13%
Assay of Sodium Hyaluronate 101.20% 97.70% 100.80% 102.70% 102.70% 100.20% 104% 101.80% 101.50% 101.30% 102.80% 100.50% 104.00%
Assay of Lactic acid 103.60% 101.00% 93.40% 91.20% 91.70% 99.50% 91.50% 94.80% 99.40% 99.70% 92.10% 95.40% 97.60%
Folding Endurance >150 >150 >150 >150 >150 >150 >150 >150 >150 >150 >150 >150 >150
Related Substances
For Sodium Hyaluronate ND ND ND ND ND ND ND ND ND ND ND ND ND
For Lactic acid
Max unknown (%) ND 0.64 0.95 1.22 1.59 0.35 0.48 0.76 1.00 0.33 0.56 0.82
Total (%) ND 1.00 1.38 1.84 1.99 0.57 0.74 1.20 1.23 0.55 0.94 1.00

Another embodiment of our present invention is given below as example 3:
Example 3

Hyaluronic acid & Lactic acid Vaginal Disintegrating Film
S No. Ingredients Function Range
% w/w
1 Hyaluronic acid (as Sodium Hyaluronate) API 1 - 15.38
2 Lactic acid API 0.5 - 10.26
3 Sodium Carboxymethyl cellulose Mucoadhesive Polymer 0.1 - 1.6
4 Hydroxypropyl methylcellulose Film-forming Polymer 20 - 76
5 Polyvinyl alcohol Co-Polymer 0.1 - 1.29
6 Propyl Paraben Preservative 0.005 - 0.5
7 Methyl Paraben Preservative 0.005 - 0.5
8 Glycerine Plasticizer 10.6 - 31.2
9 Dextrose Monohydrate Diluent 0.5 - 6
10 FD&C Yellow no.5 Colourant 0.001 - 0.2
11 Purified water Vehicle Qs

Example 3
A method of preparation of the vaginal disintegrating films, in accordance with another embodiment of our present invention comprise of the following steps:
1. Weighed quantity of purified water was taken in a SS container and kept under stirring at 350 RPM
2. Weighed quantity of Sodium Hyaluronate was added to above step-1 under stirring at 500 RPM for 30 min
3. Weighed quantity of Lactic acid was added to above step-2 under stirring at 500 RPM for 10 min
4. Weighed quantity of Sodium Carboxymethyl cellulose was added to above step-3 under stirring at 500 RPM for 10 min
5. Weighed quantity of Hydroxypropyl methylcellulose solution was added to above step-4 under stirring at 500 RPM for 15 min
6. Weighed quantity of Polyvinyl alcohol was added to above step-5 under stirring at 500 RPM for 15 min
7. Weighed quantity of Propyl paraben solution (dissolved in hot water, 60°C) was added to above step-6 under stirring at 500 RPM for 15 min
8. Weighed quantity of Methyl paraben solution (dissolved in hot water, 60°C) was added to above step-7 under stirring at 500 RPM for 5 min
9. Weighed quantity of Dextrose monohydrate was added to above step-8 under stirring at 500 RPM for 5 min
10. Weighed quantity of Glycerine was added to above step-9 under stirring at 500 RPM for 5 min
11. Weighed quantity of FD&C Yellow no.5 was added to above step-10 under stirring at 500 RPM for 5 min
12. Finally, above step- 11 Wet slurry was stirred at 500 RPM for 30 min to get uniform viscous solution
13. Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry
14. The Wet slurry was casted at process parameters of Dr. Knife thickness of 700 to 1200 microns; Temperature 95±3°C; and In-direct drying
15. The dried casted film was slitted into required dimensions for achieving the final dose

Reference product vs Test product:

The present invention is compared with the existing standard marketed products. The efficacy is tabulated in the table below.

The test product which are some of the embodiments (example 1 and example 2) of our present invention are tested against a reference product (a vaginal solution available in market) to test the following parameters and the results are tabulated below:

Study Parameters Reference product (V-Wash plus) Example - 1 Example - 2
Description A slight pale yellow color solution Light blue colored rectangular shape films Pale yellow colour rectangular shape films
pH 3.72 3.86 3.77
Osmolality 162 mOsmol/kg 110 mOsml/kg 142 mOsml/kg
Viscosity 274.2cP 359 cP 401.4 cP
Assay of Sodium Hyaluronate Not present 100.1% 101.2%
Assay of Lactic acid 109.90% 98.10% 103.60%

In an embodiment of the present invention the ease of use of the vaginal disintegrating films are well established as only they need to be inserted and do not require the use of applicators or additional devices, making them more user-friendly than vaginal solutions.

In an embodiment of the present invention the precise dosing is established over the other products existing till date. Vaginal disintegrating films of the present invention are manufactured with accurate dosages, ensuring consistent drug delivery with each use.

Vaginal films of the present invention are individually wrapped and portable, making them discreet to carry and use, even in public settings. They can be stored discreetly in a wallet or pocket and are more inconspicuous compared to bottles or tubes of vaginal solutions.

Vaginal films of the present invention dissolve quickly and evenly, reducing the chances of leakage and minimizing the potential for creating a mess during administration. As observed with vaginal solutions.

Vaginal films of the present invention are typically solid films and are designed to be stable and have a longer shelf life than vaginal solutions.
,CLAIMS:1. A vaginal disintegrating film comprising of:
Hyaluronic acid (as Sodium Hyaluronate) (API) 1 – 10 %w/w
Lactic acid (API) 0.5 – 10 %w/w
Sodium Carboxymethyl cellulose (Mucoadhesive Polymer) 0.05 – 1 %w/w
Hydroxypropyl methylcellulose (Film-forming Polymer) 20 – 85 %w/w
Propylene glycol (Plasticizer) 5.5 - 15.88 %w/w
Glycerine (Plasticizer) 0.1 – 7 %w/w
Dextrose Monohydrate (Diluent) 0.5 - 6 %w/w
FD&C Blue no.1 (Colourant) 0.001 - 0.5 %w/w
Purified water (Vehicle) Qs

2. A method of preparation of vaginal disintegrating film comprising the steps of:
Weighed quantity of purified water was taken in a SS container and kept under stirring at 350 RPM (100)
Weighed quantity of Sodium Hyaluronate was added to above step-i under stirring at 500 RPM for 30 min (101)
Weighed quantity of Lactic acid was added to above step-ii under stirring at 500 RPM for 10 min (102)
Weighed quantity of Sodium Carboxymethyl cellulose was added to above step-iii under stirring at 500 RM for 10 min (103)
Weighed quantity of Hydroxypropyl methyl cellulose solution was added to above step-iv under stirring at 500 RPM for 15 min (104)
Weighed quantity of Propylene glycol was added to above step-v under stirring at 500 RPM for 5 min (105) Weighed quantity of Glycerine was added to above step-vi under stirring at 500 RPM for 5 min (106)
Weighed quantity of Dextrose monohydrate was added to above step-vii under stirring at 500 RPM for 5 min (107)
Weighed quantity of FD&C Blue no.1 was added to above step-viii under stirring at 500 RPM for 5 min (108)
Finally, above step- ix Wet slurry was stirred at 500 RPM for 30 min to get uniform viscous solution (109)
Above step x wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry (110)
The Wet slurry was casted at process parameters of Dr. Knife thickness of 700 to 1200 microns; Temperature 95±3°C; and In-direct drying (111)
The dried casted film was slitted into required dimensions for achieving the final dose (112).